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| United States Patent |
5,027,834
|
|
Pruitt
|
July 2, 1991
|
Stapling process for use on the mesenteries of the abdomen
Abstract
The process, described herein comprise stapling a patient's mesentery and
omentum with two, three or four rows of staples, the rows being
substantially parallel to each other, the staples in all the rows having
the same crown size with alternate rows staggered one-fourth of the length
of each crown with respect to the adjacent crown in the adjacent row or
rows of staples. Advantageously the prong lengths in at least one row
differ from the prong lengths in the other row or rows. Advantageously the
longer prongs are 30-100 percent larger, preferably about 33-75 percent
larger than the smaller prongs. This arrangement is capable of
satisfactorily sealing off the variety of sizes of blood vessels and
holding firmly the fatty tissue found in the mesentery and in the omentum.
Other arrangements of staples have been designed to effect similar results
in the mesentery in which the staples having smaller and larger prongs are
arranged alternately in the same row so that the gaps between staples are
covered by staples staggered one-fourth of the crown length with respect
to staples in an adjacent row of staples.
| Inventors:
|
Pruitt; J. Crayton (St. Petersburg, FL)
|
| Assignee:
|
United States Surgical Corporation (Norwalk, CT)
|
| Appl. No.:
|
517049 |
| Filed:
|
May 1, 1990 |
| Current U.S. Class: |
128/898; 606/219 |
| Intern'l Class: |
A61B 017/00 |
| Field of Search: |
606/219
128/898
|
References Cited
U.S. Patent Documents
| 3252643 | May., 1966 | Strekopytov et al. | 227/109.
|
| 3275211 | Sep., 1966 | Hirsch et al. | 227/124.
|
| 3494533 | Feb., 1970 | Green et al. | 227/19.
|
| 3795034 | Mar., 1974 | Strekopytov et al. | 227/178.
|
| 3958738 | May., 1976 | Tremblay | 227/109.
|
| 4383634 | May., 1983 | Green | 227/19.
|
| 4520817 | Jun., 1985 | Green | 227/176.
|
| 4606345 | Aug., 1986 | Dorbond et al. | 227/181.
|
| 4667865 | May., 1987 | Judge | 227/109.
|
| 4715520 | Dec., 1987 | Roehr et al. | 227/19.
|
| 4802614 | Feb., 1989 | Green et al. | 227/19.
|
Primary Examiner: Green; Randall L.
Assistant Examiner: Jackson; Gary
Attorney, Agent or Firm: Monacelli; Walter J.
Parent Case Text
This application is a division of application Ser. No. 07/456,361 filed
Dec. 26, 1989, which is a continuation-in-part of copending application
Ser. No. 07/350,758 filed May 12, 1989, now U.S. Pat. No. 4,930,503,
issued June 5, 1990, which is a continuation-in-part of application Ser.
No. 07/237,433, filed Aug. 26, 1988, issued on July 18, 1989 as U.S. Pat.
No. 4,848,637, which in turn is a continuation-in-part of application Ser.
No. 07/060,469, filed June 11, 1987, now abandoned, which in turn is a
continuation-in-part of Ser. No. 06/864,336 filed May 19, 1986, now
abandoned.
Claims
I claim:
1. A process for preparing a mesentery of the abdomen for subsequent
removal of at least a portion of the bowel comprising the step of
preventing the flow of blood from blood vessels leading to the section of
the bowel to be removed comprising the step of applying at least two and
no more than four substantially parallel rows of staples across at least a
portion of the web of the mesentery, each staple having a crown and two
prongs extending from said crown, the staples in each of said rows having
the same length of crown with each crown being staggered substantially at
the quarter point in the length of the crown of the adjacent staple in the
adjacent row of staples, whereby the ends of looped prongs are opposite
the approximate mid-point of a looped prong on an adjacent row of staples.
2. The process of claim 1 in which there are two of said rows of staples.
3. The process of claim 2 in which there are three of said rows of staples.
4. The process of claim 2 in which the prong sizes of the staples are the
same in both rows.
5. The process of claim 4 in which the prongs of the staples in at least
one of said rows differ in size from the prongs in the remaining rows.
6. The process of claim 5 in which the prongs in the third of said rows are
shorter than the prongs in the first two of said rows.
7. The process of claim 2 in which the prongs of the staples in one row
differ in length from the prongs in the other row.
8. The process of claim 2 in which the prongs of the staples in the first
row are longer than the prongs in the second row.
9. The process of claim 1 in which there are four rows of said staples and
the prongs of the staples in at least one row are shorter than the prongs
in the remaining rows.
10. The process of claim 9 in which the prongs in the first two of said
rows are longer than the prongs in the third and fourth of said rows of
staples.
11. The process of claim 1 in which at least one of said rows has
alternating staples with longer prongs than the intermediate staples in
said row.
12. An arrangement of staples in a mesentery or omentum produced according
to the process of claim 1.
13. The process of claim 1 in which in addition to said rows of staples of
the same crown size there are at least one and no more than two additional
rows of staples of a crown size different from those of said rows of
staples.
14. The process of claim 13 in which there is one additional row of staples
of a different crown size.
Description
FIELD OF THE INVENTION
This invention relates to a process for stapling the mesenteries of a
patient's abdomen More specifically this invention relates to a process
for use in the mesenteries of a patient's abdomen of applying rows of
staples of the same crown size with the staples in alternate rows
staggered by one-quarter of the crown size with staples in the adjacent
row or rows. Still more specifically it relates to a process of applying
two, three or four rows of staples of the same crown size with at least
one row varying in prong size from the size of prongs in the other row or
rows and designed to be applied to the fatty tissue of the mesenteries so
as to seal off the blood vessels of varying size therein. It relates also
to similar results from two, three or four rows of staples of the same
crown size in which staples of large and small prong size are positioned
alternately in at least one of said rows of staples.
BACKGROUND OF THE INVENTION
The stomach, appendix, jejunum, ileum, ascending colon, transverse colon,
descending colon, liver and spleen are attached to the posterior part of
the abdominal wall by mesenteries which carry blood vessels and lymphatics
to and from these organs. The mesenteries also contain lymph nodes. The
mesenteries vary in thickness, but all contain large amounts of fatty
tissue and blood vessels which vary in size from 1.0 cm. in diameter down
to less than 0.1 mm. in diameter. The greater omentum is a double fold of
mesentery and it too carries large numbers of blood vessels of varying
size, and the thickness of the greater omentum is quite variable from one
patient to another.
There are stapling devices for closing the bronchus, pulmonary artery,
pulmonary veins, for closure of the large or small intestine, for closure
of the stomach or stapling of the stomach for morbid obesity, for
end-to-end anastomosis of the intestines, for side-to-side anastomosis of
the intestines and for individual ligation and for division of a blood
vessel. In addition, there is a variety of occluding clips for blood
vessels and skin staplers. Because of the fatty tissue and the variety of
sizes of blood vessels present in the mesentery and the omentum, the
available staplers are not satisfactory for stapling the mesentery and the
omentum. The best stapler only ligates one vessel at a time and it
commonly tears blood vessels in the vicinity of its use, requiring
time-consuming repairs after ligation of the intended vessel.
U.S. Pat. No. 4,606,345 (Dorband et al), U.S. Pat. No. 3,252,643
(Strekopytov et al), U.S. Pat. No. 3,795,034 (Strekopytov et al), Roehr et
al U.S. Pat No. 4,715,520, Tremblay U.S. Pat. No. 3,958,738 and Judge U.S.
Pat. No. 4,667,865 were cited against the parent applications.
The Dorband et al patent describes a stapler gun and a method for stapling
two staggered rows of two-part fasteners for joining body tissue with
two-part plastic fasteners which are believed to be more suitable for
remaining in the patient as compared to stainless steel staples. The
device is designed to provide two rows of fasteners, which fasteners may
be made of biologically absorbable or non-absorbable polymeric materials.
One part of the fastener comprises a U-shaped staple which has legs that
are caused to penetrate the tissue. The other part of the fastener is
placed on the other side of the tissue and used to engage the legs of the
staple and interlock therewith. There is no disclosure of staggering any
place other than the midpoint of the staples, nor is there any disclosure
of variations in the size of the fasteners, nor is there any discussion of
this arrangement being satisfactory for use with a patient's mesentery.
The Strekopytov U.S. Pat. Nos. (3,252,643 and 3,795,034) teach an older
type of device used for applying rows of staples. Neither of these patents
make reference to any differences in sizes of the staples in any of the
rows nor to any staggering other than at the midpoints of the staples.
The Roehr et al patent shows a stapler which applies three rows of
staggered staples. This patent does not show staggering of staples at any
other point than the midpoint and the staples in each row are identical in
size to the staples in size of the staples.
Applicant's U.S. Pat. No. 4,848,637 issued on July 18, 1989, and the patent
about to issue on allowed application Ser. No. 07/350,758, filed May 12,
1989 describe process, stapler and cartridge suitable for stapling the
mesentery and the omentum using two, three or four rows of staples having
different crown size in at least one row of staples as compared to the
other row of staples, including an arrangement of staples in which the
crown size of alternate staples in the same row differ from crown size of
the staples in between said alternate staples. This effective arrangement
is based on the fact that the staples having larger crowns also have
longer prongs and the prongs having smaller crowns have shorter prongs.
This is based on the fact that the prong size is determined by the
requirement to reach halfway across the bottom of the crown and also to
have enough additional length to form a loop under the crown. This loop
serves a similar function as a stitch in a suture or ligation used to seal
off the blood vessels after an incision has been made in human tissue. The
larger the loop is to be the greater will the length of the prong be in
excess of that required to reach one-half the length of the crown. With
mesentery and omentum a combination of large loops and smaller loops is
desired to seal off the flow of blood from the blood vessels severed by
the incision. Advantageously each blood vessel and also some fatty tissue
to squeeze the blood vessel shut is embraced by a loop of the staple.
When the crown sizes are the same in a number of rows of staples, as
provided in commercially available cartridges of staples, the staples in
one row are staggered with respect to the staples in the adjacent row or
rows. The staggering in each case is effected by positioning the beginning
end of the first staple in the second row of staples opposite the midpoint
of the first staple of the first row of staples. This means that the
midpoint of each of the staples in the second row of staples is opposite a
gap between staples in the first row. It also means that the gaps between
the staples in the second row are opposite the midpoint of adjacent
staples in the first row. The midpoint of the staples is where the ends of
the prongs on the underside of those staples come near to each other and
in many cases leave a gap between each other and between the prong u ends
and the crown. In some cases particularly when long prongs are used, the
grooves in the anvil have to be deeper with a sharper curvature at the
bottom of the groove thereby often causing a curve at the end of the prong
which causes a space between the prong ends in their final positions.
These conditions mean that blood vessels which come in the gaps between
staples in one row will not be encased in a loop in the adjacent row of
staples. It also is possible that a blood vessel may be punctured by one
or both of the prong ends for a staple or may be in a gap between prong
ends and the crown, or even in the space between the upper curvature of
the prong loops.
OBJECTIVE OF THIS INVENTION
It is an objective of this invention to provide a process for effectively
stapling the mesentery and the omentum
It is an objective of this invention to provide a stapler and a cartridge
therefor which is suitable for stapling the mesentery and the omentum.
It is also an objective of this invention to provide a stapling device with
appropriate arrangement of staples which will satisfactorily seal off
blood vessels of varying sizes as found in the mesentery and in the
omentum.
It is also an objective of this invention to provide an arrangement of
staples which provide prong loops opposite gaps or open spaces in an
adjacent row or rows of staples.
It is also an objective of this invention to provide an arrangement of
staples which provide prong loops opposite prong ends in an adjacent row
or rows of staples.
SUMMARY OF THE INVENTION
In accordance with the present invention a new process, a new stapler and a
new staple cartridge have been designed suitable for use on the mesentery
and on the omentum, the use of which process, stapler and cartridge are
capable of effectively stopping the bleeding of blood vessels in that part
of the mesentery or of the omentum which is being resected. These are
designed to apply two, three or four rows of staples of the same size
"crown" or main body portion of the staples, the rows being substantially
parallel to each other and the staples in each row being staggered
one-quarter of the crown length with the staples in the adjacent row or
rows of staples. Advantageously there is at least one row in which the
prong lengths of the staples differ from the length of the staple prongs
in the other row or rows.
An effective means for cutting off the flow of blood from a blood vessel in
the mesentery or omentum is to embrace the blood vessel with a curved loop
of an applied staple. This presses the fatty tissue against the wall of
the blood vessel, thereby collapsing and sealing off the blood vessel. If
the blood vessel is positioned where the two ends of the prongs meet near
the middle of the staple, it is possible for the prong end or prong ends
to puncture the blood vessel without effecting the desired seal. With many
of these staples the prong ends do not reach to the crown and sometimes to
each other, so that the resulting gaps result in ineffectiveness in the
sealing of blood vessels.
When staples having the same length in the main body portion or "crown" are
generally applied in two or three parallel rows, the staples in each row
are arranged in a staggered position with respect to staples in the
adjacent row or rows. The presently available staplers and cartridges are
designed so that the middle of each staple is opposite the gap between
staples in the adjacent row or rows. This circumstance may not be in other
parts of the body. However in the mesentery and omentery where it has been
unsatisfactory to cut off the flow of blood by staples until applicant
effected this by the use of staples of different crown sizes and
corresponding different prong lengths, as disclosed in applicant's U.S.
Pat. No. 4,848,637 issued July 18, 1989, applicant's U.S. Pat. No.
4,930,503, issued June 5, 1990. The use of different crown lengths
disturbed this regularity of having gaps in one row opposite prong ends in
an adjacent row. However if the same crown size is used in all rows but
having at least one row of staples with different sized prongs, the same
problem of having gaps in each row opposite prong ends in adjacent row or
rows again occurs.
With staples of identical crown size, it is found that effective sealing of
blood vessels in the mesentery and omentum can be effected by positioning
the staples so that the gaps between staples in one row are opposite loops
in staples of the adjacent row or rows. This positioning is effected by
having the first staple in a second row of staples shifted one-quarter of
the length of the staple with respect to the first staple in the first row
of staples. This means that in each row each gap between staples is
positioned opposite a prong loop in the adjacent row. This also means that
there is a loop opposite the prong ends in the adjacent row or rows of
staples. If there is a space between these prong ends or the prong ends do
not reach to the crown of that staple, the opposite loops in the adjacent
row of staples will seal the blood vessels missed by such prong end
spaces. This positioning of prong loops in one row opposite to gaps and
prong ends in adjacent rows effects an effective sealing of blood vessels
in the mesentery and omentum.
If the first staple of the second row of staples is moved three-quarters of
the length of the first staple in the first row, a similar effect will be
accomplished except that last staple of the second row of staples will not
have prong loops in opposite positions. Except for these end defects the
three-quarters positioning is considered the equivalent of one-quarter
positioning and is covered by claims to the one-quarter positioning.
The staple dimensions given herein apply to the length of the "crown" or
the main part of the staple and the prong lengths before being applied or
stapled. Typically, for example, vascular staples are presently available
commercially with the designation "3.0 mm.times.2.5 mm
(0.118".times.0.09") before closure. The 2.5 mm designation applies to the
length of the individual prongs and the 3.0 mm applies to the length of
the crown or main body part of the staple. Similarly a larger staple is
available with the designation "4.0 mm.times.4.5 mm (0.157".times.0.177")
before closure. Here the prong length is 4.5 mm and the length of the
crown before closure is 4.0 mm.
Advantageously the larger prongs are 30-100 percent larger, preferably
about 33-50 percent larger than the smaller prongs. The prong lengths will
also vary somewhat in accordance with the crown size.
The staple dimensions apply to the length of the main part of the staple
before being applied or stapled. For example, vascular staples are
available commercially with the designation "3.0 mm.times.2.5 mm
(0.118".times.0.098") before closure. The 2.5 mm designation applies to
the length of the individual prongs and the 3.0 mm applies to the length
of the main body part of the staple. Similarly a larger staple is
available with the designation "4.0 mm.times.4.5 mm (0.157".times.0.177")
before closure. Here the prong length is 4.5 mm and the length of the main
body portion before closure is 4.0 mm.
With the above-mentioned vascular staples, the prong length of 2.5 mm is
more than enough to reach the midpoint of the crown which is 1.5 mm from
the end of the staple. Therefore the difference or 1 mm is used in forming
the loop when the staple is closed. If a semi-circle is drawn at the
quarter point in the length of a crown with a radius equal to one-quarter
or one-fourth of the crown length, the semi-circle will reach from one end
of the crown to the midpoint of the crown. The length of this arc or
semi-circle will be 1/2 the circumference of a circle having a diameter of
1.5 mm which calculates to 1.5 or 1.5.times.3.1417 or 4.713. The
semi-circle will have half this length or 2.356 mm. This is less than the
prong length of 2.5 mm. The height of the semi-circle or loop is the
length of the line extending perpendicularly from the quarter point of the
crown to the semi-circle or loop. Therefore in this case if the prong
length is increased, the height of the resultant loop will be increased.
If the prong length is decreased, the height of the resultant loop will be
decreased.
Similarly with the above-mentioned larger staple, the prong length of 4.5
mm is more than enough to reach the midpoint of the crown which is 2 mm
from the end of the staple. Again the difference or 2.5 mm is used in
forming the loop when the staple is closed. If a semi-circle is drawn at
the quarter point in the length of the crown with a radius of one-quarter
or one-fourth of the crown length, the semi-circle will reach fron one end
of the crown to the midpoint of the crown. The length of this arc or
semi-circle will be 1/2 the circumference of a circle having a diameter of
2 mm will be 2.pi. or 2.times.3.1417 or 6.2834. The semi-circle will have
half this length or 3.1417 mm. This again is less than the prong length of
4.5 mm so that the height of the loop as described above will be
considerably greater than for the semi-circle drawn for this staple. Here
again if the prong length is increased, the height of the resultant loop
will be further increased, and if the prong length is decreased, the
height of the resultant loop will be decreased.
A variety of other staples for use on human tissue are also presently
available. These vary in crown size and prong size and also in the
closeness of the prong ends to the crown.
In the two, three or four rows of staples used in the practice of this
invention the crown size is the same throughout and the prong sizes are
sometimes varied to give the desired sealing results. As previously
mentioned, the staples in one row are staggered at the one-quarter or
one-fourth point with respect to staples in the adjacent row or rows. This
arrangement effectively positions prong loops opposite gaps between
staples or prongs ends in adjacent row or rows of staples.
With the arrangement of parallel adjacent rows of staples of the
arrangement described herein, it is possible to staple the mesentery or
omentum to stop bleeding from blood vessels as large as 1.0 cm. in
diameter down to blood vessels as small as 0.1 mm. in diameter. Moreover
these arrangements of staples are found to resist tearing of the fatty
tissue of the mesentery and of the omentum. In one modification of the
stapler of this invention a cartridge may be used which provides two rows
of staples as described above. In another modification of the stapler of
this invention a cartridge may be used which provides three rows of
staples as described. In still another modification of the stapler of this
invention a cartridge may be used which provides four rows of staples as
described above. In each case the staples are staggered at the quarter
point and preferably at least one row of staples is used which has a
different prong size from the other row or rows.
In the stapler of this invention a cartridge containing the staples of
described size and arrangement is inserted in the cartridge holder which
is opposite and parallel to the anvil portion of the device. The anvil
portion has a number of grooves of appropriate size and slope to bend the
prongs or the initially perpendicular portions of the staples as they are
thrust through the tissue and into the grooves of the anvil whereby the
prongs of the staples are turned inward and toward the main portion of the
staple. With continued pressure on the stapler, the ends of the staple are
pressed close to or against the main portion of the staple with the fatty
tissue and the blood vessels pressed in between. Preferably the prongs of
the staple when turned back toward the main part of the staple are curved
with the ends of the prongs touching or This curved structure resembles
stitching and avoids squeezing the tissue between the prongs and the main
part of the staple as would be the case if the prongs were pressed flush
against the main part of staple. This reduces the possibility of having
the staple cut through the tissue.
SPECIFIC DESCRIPTION OF THE INVENTION
The description of the process stapler and staple cartridge is simplified
by reference to the drawings.
FIG. 1 is a front view of a mesentery and the bowel connected thereto.
FIG. 2 is a similar view as in FIG. 1 with three rows of staples across the
web or narrow portion of the mesentery.
FIG. 3 is a similar view as in FIG. 1 with three rows of staples halfway
across the web and another three rows of staples continuing vertically
upward from the first three rows and extending to the bowel.
FIG. 4 is a side, elevational view of a staple positioned above a divided
groove in the anvil with the anvil portion shown in cross-section taken by
a plane coincident with and extending down from the front surface of the
staple.
FIG. 5 is a view similar to that of FIG. 4 after the prongs of the staple
have been pressed downward into the grooves of the anvil.
FIG. 6 is a top view of a stapled portion of the mesentery in which three
rows of staples having the same size crowns are positioned parallel to
each other.
FIG. 7 is a front elevational view of a preferred modification of the
stapler of this invention with the staple cartridge portion at its maximum
distance from the anvil.
FIG. 8 is a front elevational view similar to that of FIG. 7 with the
positioning rod shown advanced to a position closer to the anvil holding
portion and the trigger in an open position.
FIG. 9 is a top view of the stapler shown in FIG. 8.
FIG. 10 is an elevational cross-sectional view taken at line 10--10 of FIG.
9.
FIG. 11 is a partial side elevational view of the stapler of FIG. 8 with
the positioning rod shown in its farthest position extending into an
opening in the anvil holder with a partial cross-sectional view.
FIG. 12 is a cross-sectional view taken at line 12--12 showing the grooves
in the anvil.
FIG. 13 is a cross-sectional view taken at line 13--13 showing the staples
in the staple cartridge.
FIG. 14 is a side elevational view of a modification of the stapler of this
invention in which a replaceable cartridge of staples is used.
FIG. 15 is a cross-sectional view of the stapler of FIG. 14 taken at line
15--15.
FIG. 16 is a side elevational view similar to that shown in FIG. 14 with
the cartridge and anvil inserted and the cartridge holder advanced closer
to the anvil holder, and with a partial cross-section of the cartridge and
cartridge holder.
FIG. 17 is a side elevational view of a staples cartridge suitable for use
in the stapler of FIGS. 14-16.
FIG. 18 is a top view of the cartridge of FIG. 17.
FIG. 19 is a rear elevational view of the cartridge of FIG. 17.
FIG. 20 is a cross-sectional view taken at line 20--20 of FIG. 18.
FIG. 21 is a cross-sectional view taken at line 21--21 of FIG. 18.
FIG. 22 is a cross-sectional view taken at line 22--22 of FIG. 18.
FIG. 23 is a view of two rows of enlarged staples 6 of the same crown
length and the same prong lengths in which the rows have been moved apart
and the staples turned 90.degree. on the crowns as an axis with the
staples in the second row each staggered at the midpoint of an adjacent
staple in the first row.
FIG. 24 is a view similar to that in FIG. 23 except that the staples of the
second row are staggered at the quarter point of the staples in the first
row.
FIG. 25 is a view similar to that in FIG. 24 except that a third row is
added with staples 7 having shorter prongs than used in the first two
rows, the staples in this third row being positioned similarly to those in
the first row so that the staples in the second row are also staggered at
the quarter point of the staples in the third row.
FIG. 26 is a view similar to that in FIG. 24 except that the staples 7 in
the second row have shorter prongs than the staples 6 in the first row.
FIG. 27 is a view similar to that of FIG. 25 except that a fourth row of
staples is added with the staples in the fourth row staggered at the
quarter point with the staples in the third row.
FIG. 28 is a view of a staple before bending with dotted lines showing in
phantom the prong loops formed upon stapling.
FIGS. 29 and 30 are the top and side cross-sectional views respectively of
the front end section of a stapler as shown in FIGS. 9 and 10 but adapted
to deliver two rows of staples with alternating staples differing in prong
length.
FIG. 31 is a forward elevational view of the end portion of the stapler
shown in FIGS. 29 and 30 taken at line 31--31 of FIG. 30.
FIG. 32 is a cross-sectional view of the end portion of the stapler shown
in FIGS. 29 and 30 taken at line 32--32 of FIG. 30.
FIG. 33 is a view similar to that shown in FIG. 31 except that the grooves
in the anvil are adapted to receive staples arranged as in FIG. 26.
FIG. 34 is a view similar to that shown in FIG. 32 showing the end portions
of staples arranged as in FIG. 26.
FIG. 35 is a side elevational view of a staples cartridge suitable for use
in the end portion of the stapler of FIGS. 29 and 30.
FIG. 36 is a top view of the cartridge of FIG. 35.
FIG. 37 is a rear elevational view of the cartridge of FIG. 35.
FIG. 38 is a cross-sectional view taken at line 38--38 of FIG. 36.
FIG. 39 is a cross-sectional view taken at line 39--39 of FIG. 36.
More specifically FIG. 1 shows a mesentery 1 which has the bowel 2
surrounding the greater portion thereof. The base or web 3 of the
mesentery has large blood vessels 4 and smaller blood vessels 5 passing
therethrough and into the larger part of the mesentery.
FIG. 2 shows the mesentery as shown in FIG. 1 in which three rows of
staples of identical crown length have been applied across the web 3 of
the mesentery. There are two first rows of staples 6 having prongs longer
than the prongs in the third row of staples 7 with the staples in the
second row being staggered at the quarter point or 1/4th length of the
staples in the first and third rows, preferably with very small space
between adjacent staples so that the staples in one row overlap the
staples in the other row. This arrangement insures that both the small and
large blood vessels are compressed or sealed by this arrangement of
staples. Complete blockage of the blood vessels across the width of the
web is desirable when the complete bowel is to be removed.
FIG. 3 shows the mesentery in which half of the web has the blood vessels
sealed by a similar horizontal arrangement of three rows of staples (two
rows with larger prongs and a third row with smaller prongs) with
quarterly staggering, and a similar vertical arrangement leading from the
midpoint of the web upward to the bowel thereby sealing the blood vessels
in that area and thereby accommodating the removal of the left half of the
bowel. Lesser or larger portions of the bowel can be accommodated by
appropriate changes in the positioning of the three rows of staples as
described above.
While it is preferred to have the two rows of larger prongs positioned
first with a third row of staples with shorter prongs, it is also
contemplated that the two rows of larger prongs may be positioned outside
the rows with smaller prongs. Moreover it is also contemplated that there
may be a first row of staples with larger prongs and then two rows of
staples with smaller prongs. In each case the quarter staggering
arrangement is used. In many cases it is also suitable to use a first row
with longer prongs and on-y a second row with shorter prongs, so that
there are only two rows of staples. It is preferred however to have at
least three rows of staples as described. It is also possible to have the
first row, even the first and second rows, comprise staples with shorter
prongs with the remaining staples having longer prongs. Also contemplated
is the arrangement having two or more rows of staples alternating in each
row between longer and shorter prongs.
When reference is made to "first" row of staples this is intended to mean
the first row toward that part of the bowel which is to be retained in the
patient. The "third" row, or the "second" row where only two rows are to
be used, is that row closest to where the incision is to be made. In other
words, this first row is the row farthest from the incision site, and the
other outside row is the row closest to the incision site.
FIG. 4 shows a preferred shape of the divided groove 8 in anvil 9 with the
staple prongs 10 extending from the crown or main portion 11 of the staple
and extending toward anvil groove 8. The depth and shape of the anvil
grooves correspond to the length of the prongs to be pressed into the
grooves. Shallow grooves are used for shorter prongs and deeper grooves
are used for longer prongs.
FIG. 5 shows a preferred curved shape of the prongs 10 after the staple has
been pressed against the anvil 9 and into the divided groove 8. As
previously stated, this curved shape of the prongs resembles stitching and
reduces the pressure that might cut the tissue if uncurved or straight
prongs are pressed against the main part 11 of the staple and pressure
applied therebetween.
FIG. 6 shows a modification in which three rows of staples are applied, two
rows having staples 6 with longer prongs and a third row of staples 7 with
shorter prongs.
FIG. 7 gives a front elevational view of a modification of the stapler 14
of this invention which in part resembles a gun with handle 15, barrel 16
and trigger 30. Safety guard 29 is shown in retracted position. Anvil 17
is supported by arm 18 extending from the forward or front end of barrel
16. Staple cartridge 19 is supported by cartridge holder 20. Prongs 10 of
the staples are inside the cartridge 19 and are not visible in this view.
Positioning rod 21 passes through an opening extending through cartridge
holder 20 and also through guides 22 and 22. Knob 23 is fastened to the
back end of rod 21 and may advance the forward end of rod 21 to the anvil
by pushing knob 23 forward and may retract the rod 21 away from the anvil
by pushing knob 23 backward. Cartridge 19 is connected by an arm (not
shown here) extending inside barrel 16 and is connected indirectly to knob
24. Knob 24 is capable by a screw arrangement shown in FIG. 10 to advance
and retract the cartridge and cartridge holder. Axial rotation in a
clockwise direction advances the cartridge holder and cartridge toward the
anvil and counterclockwise rotation retracts these away from the anvil.
Gap setting 25 allows a measurement of the gap between the anvil and the
staple cartridge.
FIG. 8 is a view of the stapler similar to that of FIG. 7 except that the
positioning rod 21 has been pushed to a position closer to anvil 17 by
forward advancement of knob 23. When the anvil and cartridge are
positioned against the tissue to be stapled, further advancement of rod 21
will pierce the tissue by pointed end 21' which will eventually enter an
opening (not shown here) in anvil 17 and thereby hold the tissue in
position for the stapling operation. Trigger 30 is shown in open position.
Closing of trigger 30 toward handle 15 to the position shown in FIG. 7
actuates the forward movement of plunger 27 and plunger arm 32 (neither of
which is shown in FIG. 8 but both are shown in FIG. 10) to force the
staples into the grooves of the anvil. A partial cross-section of the
staple cartridge 19 and cartridge holder 20 shows the staple prongs 10 and
staple main portion (or crown) 11 and staple pushers 31 which are moved
forward by pusher arm 32. Pusher arm 32 is actuated by plunger arm 27
which is pivotally connected by pin 26 (not shown in FIG. 8 but shown in
FIG. 10) to trigger 30 which is pivotally connected by fulcrum pin 33.
Before trigger 30 is activated, safety bar 29 is pushed back to its
retracted position as shown in FIG. 7.
FIG. 9 is a top view of the stapler of FIG. 8 showing a partial
cross-sectional view.
FIG. 10 is an elevational cross-sectional view taken at line 10--10 of FIG.
9. In FIGS. 9 and 10, plunger 27 is connected at one end to cartridge
holder 20 and at the other end is pivotally connected to handle trigger 30
by means of pin 26. Trigger 30 is pivotally connected to the upper end of
handle 15 by means of fulcrum pin 33. Safety bar 42 is shown in position
to prevent premature or accidental movement of trigger 30. When knob 24 is
rotated, it is held in position by collar 29 of outer shell 43 while the
rotation causes advancement or retraction of screw 28 so that rotation of
the threads 35 inside knob 24 in the grooves of screw 28 will cause the
desired advancement or retraction of screw 28 which is fixed to base 36
which is fixed to both rod 27 and the top of handle 15. Thus the rotation
of knob 24 causes handle 15 and likewise plunger 27, cartridge holder 20
and staple cartridge 19 to advance toward or retract from the anvil 17' in
anvil holder 17. The lower edge of outer shell 43 is turned inwardly and
horizontally and is slidably mounted in groove 44 in the upper part of
handle 15 so that handle 15 can be moved relative to outer shell 43. When
staple holder 19 has been positioned against the tissue to be stapled, the
stapling action is activated by pressing or squeezing trigger 30. Rods 41
are fixed to outer shell 43 and extend all the way to arm 18 to which
anvil 17 is attached.
FIG. 11 is a view of the front part of the stapler of FIGS. 8 and 9 showing
the cartridge and cartridge holder 20 in a position closer to the anvil
17' in anvil holder 17.
FIG. 12 is an elevational view of the anvil 17' taken at line 12--12 of
FIG. 11. Grooves 8 and 8' are positioned to receive and turn the prongs of
the respective staple prongs. The grooves in grooves 8 are deep enough to
receive and turn the longer prongs of staples 6 whereas grooves 8' are not
as deep as grooves 8 to receive and turn the shorter prongs of staples 7.
Opening 37 is an opening in the anvil to receive the end of positioning
pin 21. Guide bar 38 is fixed to the anvil holder 17 and is adapted to fit
into an opening (not shown) in the cartridge holder.
FIG. 13 is an elevational view of the staple cartridge taken at line 13--13
of FIG. 11. Staples having the longer prongs 6 are in the second and third
rows and the staples 7 with shorter prongs are in the first. When inverted
the staples 6 will be received and bent in deeper grooves 8 and the
shorter prongs of staples 7 are received and bent in more shallow grooves
8'. The staggering of the second row of staples is as described at the
quarter point of the staples in the first and third rows. The dimensions
of the respective parts of FIGS. 12 and 13 are not according to scale but
are exaggerated to show relative positioning. Opening 37' is an opening in
the cartridge to allow passage of positioning pin 21. Guide bar 38 fits
into an opening in the cartridge holder and insures that the cartridge is
correctly positioned with respect to the anvil.
In some cases, such as shown in FIGS. 7-11, the stapler has a staple
cartridge as an integral part of the stapler, in which case the whole
stapler is discarded once the staples have been applied to the patient. In
other cases, such as in FIGS. 14-16, the stapler is adapted to receive
replaceable staple cartridges in which case the stapler may be used
repeatedly with new cartridges, with sterilization of the gun possible
after each use if considered advisable. With the use of the replaceable
cartridge the anvil may be an integral part of the stapler or may be a
replaceable anvil provided that the grooves in the anvil are registered so
that each groove is positioned opposite to the prong which it is to bend.
The replaceable anvil is fastened to the anvil holder by means of lips
extending from the anvil which slip into slots or grooves in the anvil
holder and hold the anvil in the desired registered position.
FIG. 14 is an elevational side view of a stapler 14' in which replaceable
staple cartridges and anvils may be inserted. Anvil support arm 18'
extends from the front end of barrel 16'. Cartridge holder 20' is attached
to a shaft or plunger (not shown) positioned inside barrel 16'.
Positioning pin 21' passes through an opening in cartridge holder 20' and
may have its position adjusted by pushing or pulling knob 23'. The
position of cartridge holder is adjusted by turning knob 24' which by an
internal screw arrangement (not shown) advances or retracts the cartridge
holder. Knob 24' is held in position by collar 40' while the screw device
in the interior is turned to advance or retract the plunger arm. Trigger
30' is pivotally attached to a plunger arm (not shown) inside the barrel
or sleeve 16' and by virtue of fulcrum pin 33' which gives leverage
against handle 15' for the purpose of moving the plunger arm inside of
barrel 16'. When knob 24' is rotated, it is prevented from moving axially
by collar 40' but screw 28' is caused to move out of or into the interior
of knob 24' by virtue of reciprocal threads (not shown) in the interior of
knob 24'.
FIG. 15 is a cross-sectional view taken at line 15--15 of FIG. 14 showing
the screw 28' advanced or retracted by the turning of knob 24' and thereby
advancing or retracting plunger 27'.
FIG. 16 is another side elevational view of the stapler of FIG. 14 with a
partial cross-sectional view of the cartridge holder 20' and of the
cartridge 19' shown inside the cartridge holder with a row of staples 6'.
FIG. 17 is a side elevational view of a replaceable cartridge showing the
first row of staples 6' in partial cross-sectional view, suitable for use
in the stapler of FIGS. 14-16 showing plunger manifold arm 34'" and
individual plungers 34"". Staple holder 39' has the three rows of staples
held in the interior thereof.
FIG. 18 is a top view of the staple cartridge of FIG. 17 showing manifold
plunger 34"' and three rows 34"", 34"" and 34"" of individual plungers for
the shorter pronged staples, longer pronged staples, and longer pronged
staples respectively.
FIG. 19 is a rear view of the cartridge of FIG. 17.
FIG. 20 is a cross-sectional view taken at line 20--20 of FIG. 18 showing a
row of the staples 7' having shorter prongs.
FIG. 21 is a cross-sectional view taken at line 21--21 of FIG. 18 showing
the row of staples 6' having longer prongs.
FIG. 22 is a cross-sectional view taken at line 22--22 of FIG. 1B showing a
row of staples 6' having longer prongs.
FIG. 23 shows two rows of staples with longer prongs which have been
separated a sufficient distance to allow each row to be turned 90.degree.
on the axis of the staple crowns so that the relative positions of the
prong loops and open gaps may be represented. In FIG. 23 the staples in
the second row are staggered at the midpoint of the adjacent staples in
the first row. This view shows that the loops in the second row are not
appropriately positioned to embrace blood vessels that have come through
the gaps in the first row of staples.
FIG. 24 shows a similar two rows of staples except that the staggering in
the second row starts opposite the quarter point in the staples of the
first row.
FIG. 25 shows a preferred arrangement in which two rows of staples with
longer prongs arranged as in FIG. 24 have been supplemented with a third
row of staples 7 with shorter prongs. This shows how the quarterly
staggering in each row provides loops in the second row to seal blood
vessels which may have come through gaps in the first row.
FIG. 26 shows two rows of staples in which the staples in the first row
have longer prongs than the prongs in the second row.
FIG. 27 shows an arrangement of a first two rows of staples 6 having longer
prongs followed by two rows of staples 7 having shorter prongs, in each
row the staples have the quarterly staggering arrangement with staples in
the adjacent row or rows.
FIG. 28 shows a staple with crown 40 and prongs 41. Phantom lines 42 show
the loops that will be formed upon stapling. Line 43 represents the rise
or the distance on a line perpendicular to the crown at the quarter point
of the crown. As discussed above, this rise will increase in length with
increase in prong length and will decrease in length with decrease in
prong length. With long prongs it is advantageous to have a rise greater
than 1 mm and with shorter prongs it is advantageous to have a rise lower
than 0.75 mm.
In the preceding figures the effectiveness of the staples for sealing off
the various sized blood vessels in the mesentery are dependent on using
rows of staples in which the crowns of these staples in a particular row
are of identical size but there is a staggering arrangement by which prong
loops are positioned opposite to gaps in an adjacent row of staples and
therefore capable of embracing and sealing blood vessels that may have
escaped sealing by a prior row of staples.
FIG. 29 is a top view similar to that shown in FIG. 9 but for a stapler
designed to staple two rows of staples in which each row of staples are of
alternating prong length.
FIG. 30 is a side elevational cross-sectional view taken at line 30--30 of
FIG. 29.
FIG. 31 is a forward elevational view taken at line 31--31 of FIG. 30.
In the arrangement shown in FIGS. 29 and 30 the operation of the complete
stapler is the same as for the stapler shown in and described for FIGS. 9
and 10. Plunger arm 27 advances cartridge holder 20 and causes staple
cartridge 19 to advance toward or retract from anvil 17' in anvil holder
17. In identical manner the stapling action is activated by squeezing
trigger 30 (shown in FIG. 10).
FIG. 32 is a rearward elevational view taken at line 32--32 of FIG. 30.
FIG. 33 is a similar view to that shown in FIG. 31 except that the anvil
grooves are adapted for use with staples arranged as in FIG. 26 (now
arranged vertically instead of horizontally as shown in FIG. 26.
FIG. 34 is a similar view to that shown in FIG. 32 except that the staples
are arranged as in FIG. 26 (now arranged vertically instead of
horizontally as in FIG. 26).
FIG. 35 is a side elevational view of a replaceable cartridge showing the
first row of alternating staples 6 with shorter prongs and staples 7 with
longer prongs in partial cross-sectional view, suitable for use in the
stapler of FIGS. 14-16 modified as in FIGS. 29 and 30 shown plunger
manifold arm 44. Staple holder 47 has the two rows of staples held in the
interior of cartridge 48.
FIG. 36 is a top view of the staple cartridge 48 of FIG. 35 showing
manifold plunger 44 and individual plungers 45 for the staples 6. Staple
holder 39' has two rows of staples.
FIG. 37 is a rear view of the cartridge of FIG. 35.
FIG. 38 is a cross-sectional view taken at line 38--38 of FIG. 36 showing a
row of the staples 6 with longer prongs.
FIG. 39 is a cross-sectional view taken at line 39--39 of FIG. 36 showing
the row of staples 7 with shorter prongs.
The views of staples, cartridges, etc., are not according to scale but are
merely illustrative and may be out of proportion since it is difficult to
depict exact proportions. Moreover the number of staples in a partridge is
also not representative and may vary considerably from those shown in the
figures.
The prongs generally have lengths in the range of 1/2 to 1 1/5 the length
of the main portions or crowns of the respective staples. Thus the smaller
prongs advantageously have lengths of about 1.0 to 2.75 millimeters and
the larger prongs have lengths of about 1.5 to 6.0 millimeters in length.
When there are only two rows of staples the distance between rows is
advantageously between 1.5 and 3 millimeters. The distance between the
first and third rows of staples is advantageously a maximum of about 6
millimeters and a minimum of about 3 millimeters, preferably this distance
is about 4 millimeters, and the second row of staples is advantageously
about midway between the first and third rows. When there is a fourth row
of staples, the distance between the third and fourth rows is generally
approximately the same as between the other adjacent rows.
The staples themselves may be made of any appropriate material that is
capable of being bent in the manner described and has the strength to hold
its shape once bent, provided the material does not produce an adverse
effect on or cause infection of the tissue on which it is being used.
Preferably the staples are of stainless steel of the same type as is
presently being used in the vascular staples.
In applying the staples the stapler is positioned adjacent to the
appropriate part of the mesentery or omentum with the jaws of the anvil
and the staple cartridge on opposite sides of the tissue to be stapled.
Then the pointed positioning rod 21 is pushed by means of knob 23 so that
the tissue is pierced by this pointed rod and the end of rod 21 rests in
opening 25 of the anvil so that the tissue is fixed in position with
respect to the stapler. Then the cartridge 19 and cartridge holder 20 are
advanced by axial rotation of knob 24 to a position where the cartridge is
pressed against the tissue. Then the staples are applied to the tissue and
bent into set shape by pressure actuated by the pressing of trigger 30.
After the staples have been applied, the rod 21 is retracted by pressing
backward on knob 23 and the stapler is removed.
The stapler and cartridges shown in the drawings are specified to two or
three rows of staples. Obvious modifications can be made to staples and
cartridges to provide the various arrangements of staples shown in FIGS.
23-27 and the anvils in the stapler will be modified to receive and bend
the prongs of the respective sizes and positions of the staples being
applied.
In the drawings the staples are generally represented with heavy lines
instead of the outline form and sometimes in order to avoid confusion
background material has been omitted.
In the stapler of this invention it is important that the edges,
particularly on the front of the stapler, should be well rounded to avoid
tearing the tissue with which it may come into contact.
In summary, for use in the stapler, in the cartridge and in the process of
this invention, the staples used should have the same dimension in the
crown or main portion, that is the portion connecting the two prongs,
advantageously in the range of 2.5 to 4.5 millimeters, preferably 3-4
millimeters, having this dimension in the range of 2.5 to 3.5 millimeters
and the larger staples having this dimension in the range of 3.5 to 4.5
millimeters, the larger prongs preferably being at least 30 percent longer
in this dimension than the smaller prongs. The gaps or distances between
adjacent staples in a particular row are the same as used in present day
practice, generally in the range of 1-2.5 mm, preferably 1-2 mm.
While the above descriptions have related to rows of staples having the
same crown length, it is also contemplated that these may be supplemented
by the addition of one or two rows of staples in which the crown size
differs from those in the first two or three rows of staples having the
same crown length and arranged with the quarter length staggering
described above. With different crown lengths the staggering cannot be
effected throughout except with another row of staples with the same crown
length. As an example of a supplemental row or rows of staples having
different crown length, the arrangement of FIG. 24 or FIG. 26 may be
supplemented by the addition of one or two rows of staples having a
shorter or longer crown length. It is contemplated that claims directed to
the arrangement of FIG. 24 or FIG. 26 would cover the two rows of such
Figs. with or without the one or two supplemental rows.
The following examples illustrate the ineffectiveness of two and three rows
of staples of the same size crown and prongs and arranged with staggering
at the midpoint of staples in adjacent rows. Also are examples of how the
shifting of the staggering to the quarter point of the staples in the
adjacent row will improve the effectiveness in sealing off blood vessels
in the mesentery.
EXAMPLE I
In an operation on the mesentery of a patient, the surgeon affixes two
parallel rows of staples having 3.0 mm crown and 2.5 mm prongs with the
staples in the second row staggered with the beginning end of each crown
in the second row positioned opposite the midpoint of the crown in the
adjacent staple in the first row, as illustrated in FIG. 23. Upon cutting
the mesentery distal to the stapled lines, there is profuse bleeding
requiring clamping and ligation in the traditional manner to effectively
stop the blood flow. This procedure is repeated in three subsequent
operations on the mesentery with similar results in each case.
EXAMPLE II
In another operation on a patient for whom a part of the surgeon carefully
affixes two parallel rows of staples having 4.0 mm crown and 4.5 mm prongs
with the beginning end of each crown in the second row positioned opposite
the midpoint of the crown in adjacent staple in the second row, as
illustrated in FIG. 23. When an incision is made across the area of the
mesentery to be resected distal to the staple lines and after removal of
the bowel and mesentery sections, the incision is inspected for leakage.
It is found that there is profuse blood leakage and it is necessary to
clamp the blood vessels individually and to ligate them in the traditional
manner to stop the flow of blood.
EXAMPLE III
In an operation upon a patient for whom a part of a bowel and adjoining
mesentery are to be removed, the surgeon carefully affixes across the
mesentery three parallel rows of the staples described above in Example
II. Each staple in the middle row is staggered with the beginning point of
each staple in the middle row positioned opposite the midpoint of the
adjacent staples in the first and third rows. An incision is made across
the area of the mesentery to be resected distal to the staple lines. After
the sections of the mesentery are removed, the stapled area is carefully
inspected to determine if the incision is properly sealed. It is found
that there is profuse blood leakage and that the incision is not sealed
within the recognized standard of medical care. It is then necessary to
clamp the bleeding blood vessels individually and to ligate them in a
traditional manner to stop the flow of blood.
EXAMPLE IV
In an operation upon a patient for whom a part of the bowel and adjoining
mesentery are to be removed, the surgeon carefully affixes across the
mesentery two parallel rows of staples having crown size of 4.0 mm and
prong size of 4.5 mm with the staples in the second row staggered so that
the beginning point of each crown is positioned opposite the quarter point
of the adjacent staple in the first rows in accordance with the
arrangement shown in FIG. 24. There is a marked improvement in the sealing
effectiveness of the stapling with no blood leakage.
EXAMPLE V
In an operation upon a patient for whom part of the bowel and adjoining
mesentery are to be removed, the surgeon carefully affixes across the
mesentery three parallel rows of staples. In the first two rows the
staples have crowns of 4.0 mm and prongs of 4.5 mm and the third row has
crowns of 4.0 mm and prongs of 3.5 mm. Each staple in the second row is
staggered at the quarter point of adjacent staples in the first and third
rows as shown in FIG. 25. Then after an incision is made distal to the
three lines of staples and removal of the sections of mesentery and bowel,
inspection is made of the stapled incision and it is found that the
incision is properly sealed within the recognized standard of medical
care.
EXAMPLE VI
The procedure of Example IV is repeated using staples having a crown size
of 4.0 mm in both rows with the prong size in the first row being 4.5 mm
and in the second row being 3.5 mm and the staggering being at the quarter
point as illustrated in FIG. 26. Then after an incision is made distal to
the two rows of staples and removal of the sections of mesentery and
bowel, inspection shows that the incision is properly sealed within the
recognized standard of medical care.
While reference is made herein to quarterly staggering or staggering at the
quarter point of adjacent staples in an adjacent row, it is intended that
there may be some variation from the quarterly staggering. Such variations
will be suitable so long as the loops formed by the prongs in one row will
be opposite gaps in an adjacent row of staples. This variation is covered
by the expression "substantially at the quarter point".
Furthermore, while the description of quarterly staggering refers to the
second row of staples being staggered at the quarter points of adjacent
staples in the first row, it is equally effective and equivalent to have
the first row arranged at the quarterly points of staples in the second
row. This may be demonstrated by reference to FIG. 24. Thus by
interchanging the two rows of staples, the staples of the new first row
(formerly second row) would have the beginning of the crowns positioned at
the quarter points of the respective adjacent staples in the new second
row (formerly first row). The important feature is that a loop in one row
of staples is opposite a gap in the adjacent row of staples.
In summary, staples suitable for use in the practice of this invention
advantageously have crown lengths in the range of 2.5 to 4.5 mm,
preferably 3-4 mm. Prong lengths are selected in accordance with the crown
length and the rise desired in the prong loops, and are advantageously in
the range of 1 to 6 mm, preferably in the range of 2 to 5 mm.
While certain features of this invention have been described in detail with
respect to various embodiments thereof, it will of course be apparent that
other modifications can be made within the spirit and scope of this
invention, and it is not intended to limit the invention to the exact
details insofar as they are defined in the following claims.
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